Sr. Director- GQA Global Medical Regulatory Safety

Eli Lilly and Company • Us, IN

34d • Onsite

About The Position

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Requirements

• Bachelor’s Degree or equivalent in a scientific or health-related field.
• Minimum of five (5) years relevant industry experience in quality, clinical development, safety or regulatory affairs.
• Prior line management experience.

Nice To Haves

• Advanced degree (Masters, Doctorate) in a scientific or health-related field.
• Experience in multiple facets of drug development, particularly clinical research, pharmacovigilance, regulatory affairs and product development.
• Experience in Quality Assurance or Auditing.
• A deep understanding of quality systems and business process management.
• Demonstrated ability to collaborate across boundaries and achieve results with internal and external partners.
• Experience leading change.
• Demonstrated ability to recruit and develop top talent.
• Ability to interpret and apply regulations, regulatory guidance, codes and public expectations and identify and recommend compliance changes as appropriate.
• Proven ability to synthesize information from multiple sources and make risk-based decisions.
• Excellent interpersonal skills, with proven ability to remain constructive and influential with peers, management and senior leadership, even in difficult situations.
• Ability to deliver timely and professional communications (oral and written) with precision and clarity to all levels of the organization.
• Work independently as well as collaboratively within a global team environment.
• Good analytical/problem-solving skills.

Responsibilities

• Leads the Global Quality Auditing (GQA) teams responsible for executing audits of operating units in Clinical Development (GCP), ATPLV: ADME (Absorption, Distribution, Metabolism, and Excretion), Toxicology, PK/PD (Pharmacokinetics/Pharmacodynamics), LEM (Laboratory for Experimental Medicine), Veterinary Resources (GLP), Global Patient Safety/Pharmacovigilance (GVP), Regulatory Affairs and Product Quality, including conducting GxP audits of operations in Lilly’s affiliates.
• Ensures that research conducted and sponsored by the Company, as well as product and disease state information shared with customers are in accordance with Company policies, practices and procedures and in compliance with current regulations and guidelines.
• Provides strategic input to the overall GQA audit program and interacts effectively with global quality leadership and business unit stakeholders.
• Stays abreast of the changing environment, both internal business priorities and external regulatory expectations, to identify and focus continuous improvement efforts.
• Understands the strategic and operating needs of the primary business areas to ensure that resources and quality improvements are focused on high-risk business activities.
• Leads the definition of the quality strategy and GQA audit plans for the areas of responsibility.
• Applies risk management principles to make certain the audit plans adequately cover the key risks of Lilly processes, procedures, and facilities, investigational sites, laboratories and contract research organizations, as well as other third-party collaborations.
• Assesses whether data reported in support of registration for pharmaceutical products were generated according to applicable international / national regulations and the required corporate policies and procedures.
• Communicates any potential gaps to senior management in a timely manner.
• Based on review of audit findings or trends, highlights key areas for improvement within Clinical Development, Regulatory, Safety/Pharmacovigilance and Product Quality, with appropriate escalation of issues.
• Verifies that work performed by vendors complies with Lilly and external regulatory quality requirements.
• Through engagement with pharmaceutical company peers and agency staff, seeks to understand the changing regulatory environment, and proactively adapts work and company policies and procedures to align with regulatory expectations.
• Manages and provides leadership to a global staff of quality auditors in support of the implementation of the GQA audit program, objectives, and business operations.
• Participates in component-wide QA strategic planning meetings.
• Defines strategy and action plans to continue to strengthen our GQA organization supporting Lilly’s corporate goals and objectives.
• Understands and extensively networks with the LRL functional business area management to evaluate the impact of the quality strategy and seek synergies in our operations.
• Participates actively as a member of the GQA lead team in making and supporting key decisions and providing input to the strategic direction for the component.
• Participates in business planning process for GQA.
• Manages budget and headcount to meet targets.
• Continuously assesses business needs and allocates people and finances in a manner that efficiently utilizes and grows talent/expertise and balances audit demands versus GQA capacity.
• Ensures that sufficient technical resources are available, and the optimal organization exists, through a combination of education, experience and training to execute the audit plans and provide adequate support to the relevant business areas, quality and GQA.
• Partners with each Associate Director/Director, Sr. Director and other direct reports to ensure that challenging departmental and individual objectives are established and that all employees are following the global performance management processes.
• Partners with each manager and other direct reports to verify that all team members have a robust development and career plan.
• Provides timely feedback and coaching to aid in their development.
• Maintains appropriate knowledge and experience of quality assurance and technical expertise to facilitate necessary strategy development and decision-making.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Director